半要素膳与聚合物配方用于颅脑损伤危重症患者的肠内营养：一项随机试验。
Semi-elemental versus polymeric formula for enteral nutrition in brain-injured critically ill patients: a randomized trial.
机构信息
Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, 3 bvd Alexander Fleming, 25000, Besancon, France.
EA3920, University of Franche Comté, Besancon, France.
出版信息
Crit Care. 2021 Jan 20;25(1):31. doi: 10.1186/s13054-020-03456-7.
BACKGROUND
The properties of semi-elemental enteral nutrition might theoretically improve gastrointestinal tolerance in brain-injured patients, known to suffer gastroparesis. The purpose of this study was to compare the efficacy and tolerance of a semi-elemental versus a polymeric formula for enteral nutrition (EN) in brain-injured critically ill patients.
METHODS
Prospective, randomized study including brain-injured adult patients [Glasgow Coma Scale (GCS) ≤ 8] with an expected duration of mechanical ventilation > 48 h.
INTERVENTION
an enteral semi-elemental (SE group) or polymeric (P group) formula. EN was started within 36 h after admission to the intensive care unit and was delivered according to a standardized nurse-driven protocol. The primary endpoint was the percentage of patients who received both 60% of the daily energy goal at 3 days and 100% of the daily energy goal at 5 days after inclusion. Tolerance of EN was assessed by the rate of gastroparesis, vomiting and diarrhea.
RESULTS
Respectively, 100 and 95 patients were analyzed in the SE and P groups: Age (57[44-65] versus 55[40-65] years) and GCS (6[3-7] versus 5[3-7]) did not differ between groups. The percentage of patients achieving the primary endpoint was similar (46% and 48%, respectively; relative risk (RR) [95% confidence interval (CI)] = 1.05 (0.78-1.42); p = 0.73). The mean daily energy intake was, respectively, 20.2 ± 6.3 versus 21.0 ± 6.5 kcal/kg/day (p = 0.42). Protein intakes were 1.3 ± 0.4 versus 1.1 ± 0.3 g/kg/day (p < 0.0001). Respectively, 18% versus 12% patients presented gastroparesis (p = 0.21), and 16% versus 8% patients suffered from diarrhea (p = 0.11). No patient presented vomiting in either group.
CONCLUSION
Semi-elemental compared to polymeric formula did not improve daily energy intake or gastrointestinal tolerance of enteral nutrition.
TRIAL REGISTRATION
EudraCT/ID-RCB 2012-A00078-35 (registered January 17, 2012).
背景
半要素肠内营养的特性理论上可以改善胃轻瘫的脑损伤患者的胃肠道耐受性。本研究的目的是比较半要素和聚合配方肠内营养（EN）在脑损伤危重症患者中的疗效和耐受性。
方法
纳入预计机械通气时间超过 48 小时的脑损伤成年患者（格拉斯哥昏迷评分（GCS）≤8），进行前瞻性、随机研究。
干预
肠内半要素（SE 组）或聚合（P 组）配方。EN 在入住 ICU 后 36 小时内开始，并根据标准化的护士驱动方案进行输送。主要终点是纳入后 3 天接受 60%日常能量目标和 5 天接受 100%日常能量目标的患者比例。通过胃轻瘫、呕吐和腹泻的发生率来评估 EN 的耐受性。
结果
SE 组和 P 组分别有 100 名和 95 名患者接受了分析：年龄（57[44-65]与 55[40-65]岁）和 GCS（6[3-7]与 5[3-7]）在两组之间无差异。达到主要终点的患者比例相似（分别为 46%和 48%，相对风险（RR）[95%置信区间（CI）]分别为 1.05（0.78-1.42）；p=0.73）。每日能量摄入量分别为 20.2±6.3 与 21.0±6.5kcal/kg/day（p=0.42）。蛋白质摄入量分别为 1.3±0.4 与 1.1±0.3g/kg/day（p<0.0001）。胃轻瘫的发生率分别为 18%与 12%（p=0.21），腹泻的发生率分别为 16%与 8%（p=0.11）。两组均无患者出现呕吐。
结论
与聚合配方相比，半要素配方并未改善肠内营养的每日能量摄入或胃肠道耐受性。
试验注册
EudraCT/ID-RCB 2012-A00078-35（2012 年 1 月 17 日注册）。
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